Marcus Treitl MD, Presenter: Nothing to Disclose

Maximilian F. Reiser MD, Abstract Co-Author: Nothing to Disclose

Karla Maria Treitl MD, Abstract Co-Author: Nothing to Disclose

Vascular closure devices are typically made of synthetic materials, inducing an inflammation of the vessel wall that can cause scaring over of the access vessel. A novel femoral introducer sheath and hemostatic device (FISH) introduces small intestinal submucosa (SIS), that is known from treatment of burn wounds, as a closing agent into the vessel wall. In contrast to other devices this is meant to induce wound healing instead of scaring over. We present first results of the usage of this novel closure device in daily routine.

132 consecutive patients (88 m; mean age 71,5yrs) with indication for endovascular treatment of peripheral artery disease received the FISH device for closure of the access vessel. Technical success of device deployment, the time to hemostasis, as well as the time to ambulation were recorded. Control of the access site was done by clinical examination and duplex ultrasound the following day. Small hematomas and bleedings were assessed as minor complications, whereas pseudoaneurysms or bleedings requiring surgical intervention were assessed as major complications.

Technical success was achieved in 97%. Device failure occurred in 2 cases. 2 patients developed a pseudoaneurysm that could be treated conservatively. No complication requiring surgical intervention has been observed. Mean time to hemostasis was 45 +/- 91 sec. Mean time to ambulation was 60 min. Most patients were on ASA. Mean INR was 1.11. Re-puncture of the vessel was done the next day in 6 cases without any complications. An intravascular device deployment or embolization was never observed. Re-puncture after several months was done in 12 cases without observation of scaring of the access vessel.

The novel FISH device is a safe and potent vascular closure device with excellent performance and an comparable low complication rate of 0.8%. In contrast to synthetic devices it seems to induce less scaring of the access vessel and allows immediate re-puncture without the risk of embolization.

FISH - has a broader range of suitable vessel diameters - is not contraindicated in case of calcification - is made of biologic material known from wound therapy - is believed to induce less scaring over of the access vessel. It is therefore an important alternative and new device for vascular closure after peripheral intervention.

Treitl, M, Reiser, M, Treitl, K, Evaluation of a Novel Bioabsorbable and Non-synthetic Vascular Closure Device: FISH in Daily Routine.  Radiological Society of North America 2014 Scientific Assembly and Annual Meeting, - ,Chicago IL. http://archive.rsna.org/2014/14019560.html